Core Insights - Ascentage Pharma presented promising results from a Phase Ib/II study of Lisaftoclax in combination with azacitidine for treating myeloid malignancies at the 67th ASH Annual Meeting, highlighting its potential to address unmet medical needs in this area [1][2][5] Company Overview - Ascentage Pharma Group International is a global biopharmaceutical company focused on developing novel therapies for cancer, with a strong pipeline that includes Lisaftoclax, Olverembatinib, and APG-5918 [12][14] Clinical Study Highlights - The study demonstrated a 31.8% overall response rate (ORR) in patients with venetoclax-resistant myeloid malignancies and an 80% ORR in newly diagnosed high-risk MDS/CMML [6][15] - The safety profile of Lisaftoclax was favorable, with no dose-limiting toxicities reported across all patient cohorts in the study [10][11] Drug Mechanism and Approval Status - Lisaftoclax is an orally administered Bcl-2 selective inhibitor that restores apoptosis in cancer cells and is already approved in China for CLL/SLL patients who have received prior systemic therapy [4][14] - The company is conducting four global registrational Phase III studies for Lisaftoclax in various indications, including CLL/SLL, AML, and MDS [4][16] Future Directions - Ascentage Pharma aims to accelerate clinical programs for Lisaftoclax to provide effective therapies for patients with myeloid malignancies, fulfilling its mission to address unmet clinical needs globally [5][11]

Core Viewpoint - Ascentage Pharma presented promising results from a Phase Ib/II study of Lisaftoclax in combination with azacitidine for treating myeloid malignancies at the 67th ASH Annual Meeting, highlighting its potential to address unmet medical needs in patients resistant to venetoclax [1][2][3]. Company Overview - Ascentage Pharma Group International is a global biopharmaceutical company focused on developing novel therapies for cancer, with a strong pipeline including Lisaftoclax, Olverembatinib, and APG-5918 [12][14]. Clinical Study Highlights - The study presented at ASH 2025 demonstrated a 31.8% overall response rate (ORR) in venetoclax-resistant patients and an 80% ORR in newly diagnosed high-risk MDS/CMML patients [6][15]. - The combination of Lisaftoclax and azacitidine showed a strong safety profile with no dose-limiting toxicities reported across all patient cohorts in the study involving 103 patients [10][15]. Drug Mechanism and Approval Status - Lisaftoclax is an orally administered Bcl-2 selective inhibitor that restores apoptosis in cancer cells and is currently approved in China for CLL/SLL patients who have received prior systemic therapy [4][14]. - The company is conducting four global registrational Phase III studies for Lisaftoclax across multiple indications, including CLL/SLL, AML, and MDS [4][16]. Expert Commentary - The Chief Medical Officer of Ascentage Pharma emphasized the therapeutic potential of Lisaftoclax for newly diagnosed or venetoclax-exposed patients, aiming to improve clinical management of myeloid malignancies [5].

Core Viewpoint - Ascentage Pharma's novel Bcl-2 selective inhibitor, lisaftoclax (APG-2575), has received conditional approval from China's National Medical Products Administration (NMPA) for treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously undergone at least one systemic therapy, marking it as the first Bcl-2 inhibitor approved for this indication in China and the second globally [1][3][7] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancer treatment, with a rich pipeline of innovative drug candidates, including inhibitors targeting key proteins in the apoptotic pathway [10][11] - The approval of lisaftoclax represents a significant milestone in the company's development efforts, following its first commercialized drug, olverembatinib [2][10] Product Details - Lisaftoclax is an orally administered small-molecule Bcl-2 selective inhibitor designed to restore normal apoptosis in cancer cells by blocking the antiapoptotic protein Bcl-2 [2][5] - The drug has demonstrated broad therapeutic potential in various hematologic malignancies and solid tumors, particularly in CLL/SLL, both as a monotherapy and in combination therapies [2][3] Clinical Study Insights - The approval was based on a pivotal Phase II study (APG2575CC201) that evaluated the efficacy and safety of lisaftoclax in patients with relapsed or refractory CLL/SLL, achieving a compelling overall response rate (ORR) that met the prespecified endpoint [3][4] - Lisaftoclax exhibited a favorable safety profile, with no occurrences of tumor-lysis syndrome (TLS) and manageable hematologic and non-hematologic toxicities [3][4] Market Context - CLL/SLL is a common hematologic malignancy, particularly affecting older populations, with over 100,000 new diagnoses globally each year [4] - In China, the incidence of CLL/SLL is rising, necessitating safer and more effective treatment options beyond the current primary therapies, such as BTK inhibitors, which have limitations including high relapse rates and associated toxicities [4][5][6] Future Development Plans - Ascentage Pharma is conducting four global registrational Phase III trials for lisaftoclax, including studies in combination with BTK inhibitors and in various hematologic malignancies [7][13] - The company aims to accelerate the global development of lisaftoclax to address unmet clinical needs and expand its therapeutic applications [7][13]